Rigid and flexible laparoscopic multiple component material dispensing devices and methods

ABSTRACT

A dispensing device to deliver a multiple component material to a location in vivo, the device including a manifold having proximal and distal ends and multiple separate lumens within it, connectable on its proximal end to multiple syringes for containing the multiple component material, a distal tip assembly comprising a tip connector having separate side-by-side lumens within the tip connector and optionally a dispensing tip, and multiple flexible side-by-side cannulae, each having a proximal end and a distal end, the proximal ends of the cannulae each connected to a separate lumen at the distal end of the manifold, and the distal ends of the cannulae each connected to one of the side-by-side lumens of the tip connector, establishing a fluid communication between the manifold and the distal tip assembly, wherein said side-by-side cannulae are optionally partially connected along their length and are split at their proximal and distal ends.

FIELD

This invention relates to a dispensing device for multiple componentmaterials used in medical or surgical procedures.

ENVIRONMENT

In recent years, minimally invasive surgical techniques have emerged asan alternative to conventional surgical techniques to perform aplurality of surgical procedures. Minimally invasive procedures differfrom conventional surgical procedures in that a plurality of devices maybe introduced into the body through a small incision. As a result,trauma to the body is greatly reduced, thereby decreasing the recoverytime of the patient.

One example of a common minimally invasive surgery involves laparoscopicsurgical procedures. Laparoscopic procedures may be used to treathernias, colon dysfunctions, gastroesophageal reflux disease,gallbladder disorders, etc. Typically, the patient undergoing theprocedures will return home hours after undergoing surgery.

One challenge presented when performing minimally invasive surgicalprocedures relates to closing an incision made within the patient's bodyby a cutting laparoscopic instrument. As opposed to conventionalsurgical procedures, the surgeon's access to the site of the incision isgreatly reduced during minimally invasive procedures.

Recently, the use of tissue sealants and other biological adhesivematerials has emerged as an alternate technique of closing incisions.Such tissue sealants may include fibrin, which is comprised of thrombinand a fibrinogen material, although other multiple component materialsare available. Typically, the individual components of the adhesivematerial are stored in isolated reservoirs. When mixed, these componentsmay coagulate very quickly, yielding an adhesive gel within a shortperiod of time, perhaps 10 or 20 seconds. When applied to the exteriorof the body, or when considerable access to the application site ispossible, the rapid coagulative properties of the tissue sealant areadvantageous. However, such fast-acting properties of conventionaltissue sealants and adhesive have presented potential problems offouling or clogging during the application of tissue sealants throughlaparoscopic devices, which typically results in the destruction of thedevice.

Additionally, it is difficult to manufacture flexible accessories fordelivering a two component material to a location in vivo. Thecomponents of the material are stored separately in and expressed out ofa dual syringe, which requires a minimum distance between the exitorifices of the dual syringe. To be functional, the flexible cannulamust be significantly smaller than the minimum distance between the exitorifices of the dual syringe, which results in two physically separatedfluid paths coming together to fit into the cannula.

Multilumen tubing is difficult to extrude and cut while providingpatency of each lumen, repeatable shapes, and clean surfaces forbonding. Current devices and methods use very challenging overmoldingprocesses with bent core pins, which results in high scrap rates, or useadditional components such as bent hypotubes, which add cost andcomplexity to the assembly of the device.

Thus, there is a need for a device capable of effectively delivering amultiple component tissue sealant to a location in vivo from a remotelocation, which is easily and reproducibly manufactured.

SUMMARY

Presented herein is a dispensing device to deliver a multiple componentmaterial to a location in vivo, the device comprising a manifold havingproximal and distal ends and multiple separate lumens within it,connectable on its proximal end to multiple syringes for containing themultiple component material, a distal tip assembly comprising a tipconnector having separate side-by-side lumens within the tip connectorand optionally a dispensing tip, and multiple flexible side-by-sidecannulae, each having a proximal end and a distal end, the proximal endsof the cannulae each connected to a separate lumen at the distal end ofthe manifold, and the distal ends of the cannulae each connected to oneof the side-by-side lumens of the tip connector, establishing a fluidcommunication between the manifold and the distal tip assembly, whereinsaid side-by-side cannulae are optionally partially connected alongtheir length and are split at their proximal and distal ends.

In one form, the tip connector is provided with an external thread forconnecting a threaded dispensing tip and a barbed proximal end.

In one form, the distal ends of the cannulae are retained within theside-by-side lumens of the tip connector with an adhesive or byovermolding the cannulae in the lumens.

In another form, the dispensing device further comprises a housingenclosing at least a portion of the cannulae and the manifold.

In yet another form, the tip connector comprises a distal end having twoapertures, each in fluid connection with one of the side-by-side lumenstherein, and can further include at least one flat surface on an outersurface thereof, or even multiple flat surfaces on an outer surfacethereof.

In one form, the dispensing device further comprises a rigid overtubethrough which the side-by-side cannulae extend, the rigid overtubeextending between the distal tip assembly and a housing enclosing atleast a portion of the manifold.

In another form, a barbed proximal end of the tip connector is disposedin a distal end of the rigid overtube, and the rigid overtube comprisesat least one tab biased inward to retain the tip connector.

In yet another form, the barbed proximal end of the tip connector isdisposed in a distal end of the rigid overtube, and the rigid overtubecomprises at least one slot in the distal end of the rigid overtube toalign with a keying feature of the tip connector to resist rotation ofthe tip connector in the rigid overtube.

In another form, the dispensing device comprises a flexible overtube anda grommet through which the side-by-side cannulae extend, the grommetbeing disposed in a distal end of a housing enclosing at least a portionof the manifold, and the flexible overtube extending between the tipconnector and into the grommet.

Advantageously, the grommet comprises a barbed distal end over which theflexible overtube is disposed and the tip connector comprises a barbedproximal end over which the flexible overtube is disposed.

Conveniently, the flexible side-by-side cannulae are partially connectedalong their length.

In one form, the manifold of the dispensing device is a U- or H-shapedconnector, hereinafter described as an H-connector, having two separatelumens extending therethrough, such as wherein the distal ends of thetwo separate lumens in the H-connector each comprise a first region anda second region, the first region being distal with respect to thesecond region, the first region having a diameter greater than thesecond region. In this form, the first region has a greater taper thanthe second region.

Conveniently, the proximal ends of the cannulae are retained within thesecond regions of the two separate lumens with an adhesive or byovermolding the cannulae in the lumens.

In another form, the proximal ends of the manifold comprise Luer-taperconnections for the syringes. Optionally, the manifold is slidablydisposed within the housing and the Luer-taper connections provide foran angular displacement relative to a centrally aligned position

Advantageously, the dispensing device further comprises a brace disposedat a proximal end of the housing to secure the manifold therein,extending proximally from the housing to engage with a frame for thesyringes, to align the syringes with the manifold.

Additionally presented is a method for delivering a multiple componentmaterial to a location in vivo, comprising supplying separate componentsof the multiple component material in separate syringes, compressingplungers of the separate syringes to deliver the multiple components toa manifold within a housing, the manifold having proximal and distalends and multiple separate lumens within it, connected on its proximalend to the syringes and on its distal end to multiple flexibleside-by-side cannulae, each having a proximal end and a distal end, theproximal ends of the cannulae each connected to a separate lumen at thedistal end of the manifold, the distal ends of the cannulae connected toa distal tip assembly comprising a tip connector having separateside-by-side lumens within the tip connector and optionally a dispensingtip, each lumen connected to one of the flexible side-by-side cannulae,wherein said side-by-side cannulae are optionally partially connectedalong their length and are split at their proximal and distal ends, andpassing the multiple components into the tip connector, optionallythrough the dispensing tip and then to the in vivo location.

In one form, the multiple flexible side-by-side cannulae have a rigidovertube extending between the manifold housing and the tip connector.

In another form, the multiple flexible side-by-side cannulae have aflexible overtube extending between the manifold housing and the tipconnector.

Advantageously, the separate components do not contact one another untilentering or exiting the dispensing tip.

BRIEF DESCRIPTION OF THE DRAWINGS

The forms disclosed herein are illustrated by way of example, and not byway of limitation, in the figures of the accompanying drawings and inwhich like reference numerals refer to similar elements and in which:

FIG. 1A is an illustration of a delivery device having a flexibleovertube, and FIG. 1B is an illustration of the device having a rigidovertube. FIG. 1C is a distal view of either device of FIGS. 1A or 1Bwithout the overtube, and FIG. 10 is a view of the proximal end of thedevice housing;

FIGS. 2A to 2G are views of the tip connector of the delivery device;

FIGS. 3A to 3D are views of the manifold of the delivery device;

FIGS. 4A to 4D are views of the rigid overtube useful with the deliverydevice;

FIGS. 5A and 5B are views of the flexible overtube useful with thedelivery device;

FIGS. 6A and 6B are cutaway views of housings used for the flexibleovertube and rigid overtube versions of the delivery devices,respectively;

FIGS. 7A to 7E are views of a grommet useful with the flexible overtubeversion of the delivery device; and

FIG. 8 is an illustration of the proximal end of the delivery deviceconnected to a multiple syringe holder.

DETAILED DESCRIPTION

Described herein is a medical device and process for maintainingreactive components of a multiple component material separate for aslong as possible, especially during delivery to a location at which theyare to be mixed and reacted.

Each of the following terms written in singular grammatical form: “a,”“an,” and “the,” as used herein, may also refer to, and encompass, aplurality of the stated entity or object, unless otherwise specificallydefined or stated herein, or, unless the context clearly dictatesotherwise. For example, the phrases “a device,” “an assembly,” “amechanism,” “a component,” and “an element,” as used herein, may alsorefer to, and encompass, a plurality of devices, a plurality ofassemblies, a plurality of mechanisms, a plurality of components, and aplurality of elements, respectively.

Each of the following terms: “includes,” “including,” “has,” “'having,”“comprises,” and “comprising,” and, their linguistic or grammaticalvariants, derivatives, and/or conjugates, as used herein, means“including, but not limited to.”

It is to be understood that the various forms disclosed herein are notlimited in their application to the details of the order or sequence,and number, of steps or procedures, and sub-steps or sub-procedures, ofoperation or implementation of forms of the method or to the details oftype, composition, construction, arrangement, order and number of thesystem, system sub-units, devices, assemblies, sub-assemblies,mechanisms, structures, components, elements, and configurations, and,peripheral equipment, utilities, accessories, and materials of forms ofthe system, set forth in the following illustrative description,accompanying drawings, and examples, unless otherwise specificallystated herein. The apparatus, systems and methods disclosed herein canbe practiced or implemented according to various other alternative formsand in various other alternative ways.

It is also to be understood that all technical and scientific words,terms, and/or phrases, used herein throughout the present disclosurehave either the identical or similar meaning as commonly understood byone of ordinary skill in the art, unless otherwise specifically definedor stated herein. Phraseology, terminology, and, notation, employedherein throughout the present disclosure are for the purpose ofdescription and should not be regarded as limiting.

Presented herein is a dispensing device to deliver a multiple componentmaterial to a location in vivo, the device comprising a manifold havingproximal and distal ends and multiple separate lumens within it,connectable on its proximal end to multiple syringes for containing themultiple component material, a distal tip assembly comprising a tipconnector having separate side-by-side lumens within the tip connectorand optionally a dispensing tip, and multiple flexible side-by-sidecannulae, each having a proximal end and a distal end, the proximal endsof the cannulae each connected to a separate lumen at the distal end ofthe manifold, and the distal ends of the cannulae each connected to oneof the side-by-side lumens of the tip connector, establishing a fluidcommunication between the manifold and the distal tip assembly, whereinsaid side-by-side cannulae are optionally partially connected alongtheir length and are split at their proximal and distal ends.

Aspects of the disclosed device provide a robust and simple design fordelivering a multiple component material to a location, especially alocation in vivo. In one form, the device incorporates side-by-sidecannulae which are connected at their proximal ends to a manifold fordelivering the multiple component material, and at their distal ends tothe side-by-side lumens of a tip connector, such that fluidcommunication is established between the manifold and the tip connectorthrough the side-by-side cannulae. Optionally, the side-by-side cannulaecan be in the form of a “paratube”, which is two extruded cannulaepressed together along their long axes, side-by-side, before the coolingquench of the extrusion process. The resulting paratube provides twoseparate, flexible, side-by-side cannulae connected, or heat sealed,together but still separable, completely or along only a desired lengthof the paratube. In a fibrin sealant application accessory, the paratubeis split along a portion of its length, and at the split, individualcannula for conveying each component of a fibrin sealant are disposedand adhered to various Luer-type adapters via several different routes.

For example, the paratube may extend between a proximal manifold and adistal tip assembly via a grommet and a housing. In such case, theparatube may extend between the grommet and the distal tip assemblythrough a flexible overtube. As another example, the paratube may extendbetween the proximal manifold and the distal tip assembly via a rigidovertube disposed at least partially in the housing.

Further, whether the dispensing device is flexible or rigid, the housingmay include a brace to engage and align a dual syringe containing themultiple component material or the housing may be configured to accept abrace to engage and align a dual syringe and to secure the manifold inthe housing.

FIGS. 1A and 1B illustrate overall views of the presently discloseddelivery device 100, except that FIG. 1A shows the flexible version ofthe device and FIG. 1B shows the rigid version of the device. Eachversion has a distal tip assembly 110 which comprises at least a tipconnector 120 (not shown in FIG. 1 B) and optionally a dispensing tip112. The dispensing tips are for the most part conventional and can beused as either spray-type or drip-type tips. Also, each version has ahousing 140 which encloses a manifold (not shown) from which Luer-typeconnections 165 extend from the proximal side of the housing, forconnection to multiple syringes containing the multiple componentmaterial. The flexible version of the delivery device has a flexibleovertube 130 a which fits into a supporting grommet 142 in housing 140,while the rigid version has a rigid overtube 130 b which fits directlyinto housing 140, both overtubes encasing the side-by-side cannulae or aparatube 132 (FIG. 1C), which side-by-side cannulae can be cut todifferent lengths overall to accommodate the different lengths of theflexible and rigid versions of the delivery device. It should be notedthat the device can be structured and arranged without an overtube, ifdesired. FIG. 1D shows the proximal end of housing 140 with Luer-typeconnections 165 extending through the housing, and a brace 150,structured and arranged to connect to a frame for containing themultiple syringes. The brace provides for both easy alignment of thesyringe tips and resistance to rotational torque on the housing, toprovide a load path for any torque moment between the syringes and thehousing so as to not damage the Luer connections.

FIGS. 2A through 2G illustrate the tip connector 120 which has aconical, barbed proximal end 122 and in this form a threaded distal end124, to accommodate conventional dispensing tips 112 having matchinginternal threads, which can be used in a spray-type or drip-type mode,depending on the extent of pressure exerted on the syringes containingthe multiple component material. Of course, the connection can be variedto any suitable and sturdy connection, such as for example a snap-typeconnection, wherein tip connector 120 has an annular bead around theouter circumference on the distal end and the dispensing tip 112 has amatching undercut on its inner circumference. The barbed proximal end122 of the tip connector 120 is structured and arranged to fit securelywithin either the flexible overtube 130 a or the rigid overtube 130 b,as will be discussed below. Tip connector 120 is configured to have atleast one flat surface 126 on its exterior surface, or even multipleflat surfaces 126, which make manipulation of the tip connector 120 witha medical provider's gloved hands much easier. For example, if thedispensing tip 112 becomes clogged by premature mixing of the thrombinand fibrinogen materials, the dispensing tip can be more easily removedand replaced by the medical worker gripping the flat surfaces 126 of tipconnector 120, as compared to a connector having an annularcircumference on the exterior surface. This is especially true when thetip connector 120 has a threaded distal end 124 and removal andreplacement of the dispensing tip 112 requires holding the tip connector120 steady while the clogged dispensing tip 112 is unscrewed.

Tip connector 120 is also provided with two separate, side-by-sidelumens 121 a and 121 b which extend through the connector and match theorientation of the side-by-side cannulae 132 of in this case a paratubeon the proximal end (FIG. 2E) of the tip connector 120. The diameters oflumens 121 a and 121 b are slightly larger than those of the cannulae,such that the side-by-side cannulae can be split at the distal end andseparately inserted into lumens 121 a and 121 b. Advantageously, anadhesive is deposited in lumens 121 a and 121 b before or afterinsertion of the separated cannulae to fix them into place within thetip connector 120. Alternatively, the tip connector can be overmoldedonto the tubing (either split and slightly separated, or not), or thetubing could be cut to slightly different lengths to minimize the chanceof premature contact of the multiple components of the multiplecomponent material in the instance that the over-molding is notcompletely sealed to the tubing.

The distal end of tip connector 120 can be provided with “D” shaped exitports 125 a and 125 b (FIG. 2F), which are larger in size than lumens121 a and 121 b, and thus easier to unclog, if necessary.

Tip connector 120 is additionally provided with a keying feature 127,which helps to resist rotation of the tip connector 120 when it is usedwith a rigid overtube. The particulars of this structure will bedescribed in more detail below. FIG. 2G shows an alternative tipconnector 120 design, wherein the barbed proximal end 123 is relativelyflat rather than conical. In this view the insertion of separated distalcannulae 132 b is evident.

FIGS. 3A through 3C illustrate the manifold 160, which in this case isan H-connector, having two Luer-like connectors 165 on the proximal endfor connection to multiple syringes containing the multiple componentmaterial. As can be seen in cross-sectional view FIG. 3B, the manifold160 is provided with two separate lumens 161 a and 161 b, which extendfrom the distal ends of the Luer-like connectors 165 through themanifold 160, thus providing two separate fluid paths through themanifold. The distal ends of the two separate lumens 161 a and 161 b arestructured and arranged to have first and second regions, the firstregions 161 c being distal to the second regions 161 d and havinggreater diameters to accommodate the split proximal ends 132 a of theside-by-side cannulae of the paratube (FIG. 3C) and simplify assembly ofthe dispensing device 100. Conveniently, the first regions 161 c havegreater tapers than the second regions 161 d.

Again, it is advantageous if an adhesive is deposited in at least secondregions 161 d before or after insertion of the split paratube ends 132 ato secure them into place within the manifold 160. Alternatively, theparatube ends can be overmolded within the manifold ends 161 d.

Accordingly, it is clear that the manifold 160 and the tip connector 120are in fluid communication by virtue of the side-by-side cannulae 132attached to each, and in combination provide two separate fluid pathsthrough the delivery device 100.

FIG. 3D shows the location of the H-connector within housing 140. Theexterior of the H-connector is provided with two ridges 300, one oneither side, which is a raised narrow rim which only partially surroundsthe distal portions of the connector, such as being semi-circular.Likewise, the exterior of the H-connector is provided with two flanges315 proximal to the ridges 300 which completely surround this portion ofthe connector. Ridges 300 and flanges 315 are separated by grooves 310,which fit against pins 320 molded into housing 140. The widths of thegrooves is larger than the widths of the pins, such that the H-connectoris provided with a relatively loose and slidable fit, such that theridges 300 and pins 320 constrain the H-connector from sliding too farproximally, and the flanges 315 and pins 320 constrain the H-connectorfrom sliding too far distally within housing 140. When either both ofthe ridges 300 or both of the flanges 315 are constrained against pins320, the H-connector is centrally aligned within the housing. Thisslidable configuration of the H-connector is advantageous, as itprovides flexibility to the fixation of the H-connector within thehousing 140, as well as providing the Luer-like connectors 165 with someflexibility and limited movement outside of the housing 140, whichenables easier attachment of the dual syringes 200 (FIG. 8) to theLuer-like conectors. In some embodiments there can be angular movementof the Luer-like connectors 165 relative to the centrally alignedposition within the housing 140 of about 3-15 degrees, proximally anddistally, such as 5 degrees, 8 degrees, 10 degrees, 12 degrees or even15 degrees, so that the total angular movement or amplitude can be fromabout 6 to about 30 degrees.

FIGS. 4A through 4D show various views of the rigid overtube 130 b,which can be made of any suitable rigid material capable ofsterilization, such as stainless steel or any number of rigid polymers.FIG. 4B is a cutaway of the distal end of rigid overtube 130 b, whichshows a slot 134 which coordinates with keying feature 127 of tipconnector 120 to help align the tip connector 120 with the rigidovertube 130 b and prevent rotation of the connector within theovertube. Additionally, as shown in FIGS. 4C and 4D, the distal end ofthe rigid overtube is provided with at least one tab 136 which is biasedinward, i.e. towards the interior of the tube. This tab 136 acts tocapture the proximal barbed end 122 of tip connector 120 when the barbedend is inserted into the rigid overtube 130 b, preventing the tipconnector 120 from being inadvertently withdrawn from the overtube.

Alternatively, the overtube can be a flexible overtube 130 a, asdepicted in FIGS. 5A and 5B. The flexible overtube 130 a can be made ofany number of flexible materials, such as plastics or elastomers or thelike which are capable of sterilization. The flexible overtube 130 a incombination with the flexible side-by-side cannulae 132 of the paratubeinside of the overtube enables the surgeon to access difficult to reachlocations in vivo. The inner diameter of flexible overtube 130 a islarge enough to accommodate both the side-by-side cannulae 132 of theparatube and the barbed proximal end 122 of tip connector 120, which isheld in place by the elasticity of the flexible overtube.

FIGS. 6A and 6B depict two versions of a lower portion of housing 140,illustrating the fluid connections between the manifold 160 and theproximal split ends 132 a of the side-by-side cannulae 132 of theparatube. In FIG. 6A it can be seen that the distal end of housing 140is provided with a grommet 142, which helps support the flexibleovertube 130 a, not shown in this view for clarity, and the side-by-sidecannulae 132 inside of it. The proximal ends 132 a of the side-by-sidecannulae 132 are split and optionally routed through various pegs withinthe housing 140 to the separate lumens of the manifold 160. Similarly,FIG. 6B shows the location of rigid overtube 130 b, which extends wellinto housing 140 and as such does not need a grommet for support.

FIGS. 7A through 7C illustrate the grommet 142 used with the flexibleovertube 130 a version of the delivery device 100. The grommet has aninternal void 146 large enough to accommodate the side-by-side cannulaeor paratube 132, and a barbed distal end 144 which fits snugly into theflexible overtube 130 a in much the same way as the proximal barbed end122 of tip connector 120.

FIG. 8 illustrates the proximal end of the presently disclosed deliverydevice 100, including housing 140, rigid overtube 130 b and brace 150attached to the frame of a multiple syringe 200 having plungers 210.Upon pressing the plungers 210 which are ganged together, the separatecomponents of the multiple component material in each syringe aredelivered to the manifold 160, through the side-by-side cannulae 132 orparatube, down to the tip connector 120, through the dispensing tip andultimately to the in vivo location to be treated.

Additionally presented is a method for delivering a multiple componentmaterial to a location in vivo, comprising supplying separate componentsof said multiple component material in separate syringes, compressingplungers of said separate syringes to deliver said multiple componentsto a manifold within a housing, the manifold having proximal and distalends and multiple separate lumens within it, connected on its proximalend to said syringes and on its distal end to multiple flexibleside-by-side cannulae, each having a proximal end and a distal end, theproximal ends of the cannulae each connected to a separate lumen at thedistal end of said manifold, the distal ends of the cannulae connectedto a tip connector having separate side-by-side lumens within theconnector, each lumen connected to one of the flexible side-by-sidecannulae, wherein said side-by-side cannulae are optionally partiallyconnected along their length and are split at their proximal and distalends, and passing the multiple components into a dispensing tipconnected to the tip connector and then to the in vivo location.

PCT1. A dispensing device to deliver a multiple component material to alocation in vivo, the device comprising a manifold having proximal anddistal ends and multiple separate lumens within it, connectable on itsproximal end to multiple syringes for containing the multiple componentmaterial, a distal tip assembly comprising a tip connector havingseparate side-by-side lumens within the tip connector and optionally adispensing tip, and multiple flexible side-by-side cannulae, each havinga proximal end and a distal end, the proximal ends of the cannulae eachconnected to a separate lumen at the distal end of the manifold, and thedistal ends of the cannulae each connected to one of the side-by-sidelumens of the tip connector, establishing a fluid communication betweenthe manifold and the distal tip assembly, wherein said side-by-sidecannulae are optionally partially connected along their length and aresplit at their proximal and distal ends.

PCT2. The dispensing device according to paragraph PCT1, wherein the tipconnector is provided with an external thread for connecting a threadeddispensing tip and a barbed proximal end.

PCT3. the dispensing device according to paragraphs PCT1 or PCT2,wherein the distal ends of the cannulae are retained within theside-by-side lumens of the tip connector with an adhesive or byovermolding the cannulae in the lumens.

PCT4. the dispensing device according to any of paragraphs PCT1 to PCT3,further comprising a housing enclosing at least a portion of thecannulae and the manifold.

PCT5. the dispensing device according to any of paragraphs PCT1 to PCT4,wherein the tip connector comprises a distal end having two apertures,each in fluid connection with one of the side-by-side lumens therein,and can further include at least one flat surface on an outer surfacethereof, or even multiple flat surfaces on an outer surface thereof.

PCT6. the dispensing device according to any of paragraphs PCT1 to PCT5,further comprising a rigid overtube through which the side-by-sidecannulae extend, the rigid overtube extending between the distal tipassembly and the housing enclosing at least a portion of the manifold.

PCT7. the dispensing device according to any of paragraphs PCT1 to PCT6,wherein a barbed proximal end of the tip connector is disposed in adistal end of the rigid overtube, and the rigid overtube comprises atleast one tab biased inward to retain the tip connector.

PCT8. the dispensing device according to paragraph PCT7, wherein thebarbed proximal end of the tip connector is disposed in a distal end ofthe rigid overtube, and the rigid overtube comprises at least one slotin the distal end of the rigid overtube to align with a keying featureof the tip connector to resist rotation of the tip connector in therigid overtube.

PCT9. the dispensing device according to any of paragraphs PCT1 to PCT5,further comprising a flexible overtube and a grommet through which theside-by-side cannulae extend, the grommet being disposed in a distal endof a housing enclosing at least a portion of the manifold, and theflexible overtube extending between the tip connector and the grommet.

PCT10. the dispensing device according to paragraph PCT9, wherein thegrommet comprises a barbed distal end over which the flexible overtubeis disposed and the tip connector comprises a barbed proximal end overwhich the flexible overtube is disposed.

PCT11. the dispensing device according to any of paragraphs PCT1 toPCT10, wherein the flexible side-by-side cannulae are partiallyconnected along their length.

PCT12. the dispensing device according to any of paragraphs PCT1 toPCT11, wherein the manifold of the dispensing device is an H-connectorhaving two separate lumens extending therethrough, such as wherein thedistal ends of the two separate lumens in the H-connector each comprisea first region and a second region, the first region being distal withrespect to the second region, the first region having a diameter greaterthan the second region, and the first region has a greater taper thanthe second region.

PCT13. the dispensing device according to paragraph PCT11, wherein theproximal ends of the cannulae are retained within the second regions ofthe two separate lumens with an adhesive or by overmolding the cannulaein the lumens.

PCT14. the dispensing device according to any of paragraphs PCT1 toPCT13, wherein the proximal ends of the manifold comprise Luer-taperconnections for the syringes, and optionally the manifold is slidablydisposed within the housing and the Luer-taper connections provide foran angular displacement relative to a centrally aligned position

PCT15. the dispensing device according to any of paragraphs PCT3 toPCT14, further comprising a brace disposed at a proximal end of thehousing to secure the manifold therein, extending proximally from thehousing to engage with a frame for the syringes, to align the syringeswith the manifold.

PCT16. A method for delivering a multiple component material to alocation in vivo, comprising supplying separate components of saidmultiple component material in separate syringes, compressing plungersof said separate syringes to deliver said multiple components to amanifold within a housing, the manifold having proximal and distal endsand multiple separate lumens within it, connected on its proximal end tosaid syringes and on its distal end to multiple flexible side-by-sidecannulae, each having a proximal end and a distal end, the proximal endsof the cannulae each connected to a separate lumen at the distal end ofsaid manifold, the distal ends of the cannulae connected to a distal tipassembly comprising a tip connector having separate side-by-side lumenswithin the tip connector and optionally a dispensing tip, each lumenconnected to one of the flexible side-by-side cannulae, wherein saidside-by-side cannulae are optionally partially connected along theirlength and are split at their proximal and distal ends, and passing themultiple components into the tip connector, optionally through thedispensing tip and then to the in vivo location.

PCT17. the method of paragraph PCT16, wherein the multiple flexibleside-by-side cannulae have a rigid overtube extending between themanifold housing and the tip connector.

PCT18. the method of paragraph PCT16, wherein the multiple flexibleside-by-side cannulae have a flexible overtube extending between themanifold housing and the tip connector.

PCT19. the method of paragraphs PCT16 to PCT18, wherein the separatecomponents do not contact one another until entering or exiting thedispensing tip.

INDUSTRIAL APPLICABILITY

The systems and methods disclosed herein are applicable to the medicaldevice industry.

It is believed that the disclosure set forth above encompasses multipledistinct inventions with independent utility. While each of theseinventions has been disclosed in its preferred form, the specificembodiments thereof as disclosed and illustrated herein are not to beconsidered in a limiting sense as numerous variations are possible. Thesubject matter of the inventions includes all novel and non-obviouscombinations and subcombinations of the various elements, features,functions and/or properties disclosed herein. Similarly, where theclaims recite “a” or “a first” element or the equivalent thereof, suchclaims should be understood to include incorporation of one or more suchelements, neither requiring nor excluding two or more such elements.

It is believed that the following claims particularly point out certaincombinations and subcombinations that are directed to one of thedisclosed inventions and are novel and non-obvious. Inventions embodiedin other combinations and subcombinations of features, functions,elements and/or properties may be claimed through amendment of thepresent claims or presentation of new claims in this or a relatedapplication. Such amended or new claims, whether they are directed to adifferent invention or directed to the same invention, whetherdifferent, broader, narrower, or equal in scope to the original claims,are also regarded as included within the subject matter of theinventions of the present disclosure.

1-24. (canceled)
 25. A dispensing device to deliver a multiple componentmaterial to a location in vivo, the device comprising: a manifold havinga proximal end and a distal end and multiple separate lumens within saidmanifold, connectable on the proximal end of the manifold to multiplesyringes for containing the multiple component material; a distal tipassembly comprising a tip connector having separate side-by-side lumenswithin the tip connector and an external thread at a distal end of thetip connector for connecting a threaded dispensing tip; multipleflexible side-by-side cannulae, each having a proximal end and a distalend, the proximal end of the cannulae each connected to a separate lumenat the distal end of said manifold, and the distal end of the cannulaeeach connected to one of the side-by-side lumens of said tip connector,establishing a fluid communication between said manifold and said distaltip assembly, wherein said side-by-side cannulae are optionallypartially connected along a length and are split at the proximal end andthe distal end; and a rigid tube through which the side-by-side cannulaeextend, the rigid tube extending between the distal tip assembly and ahousing enclosing at least a portion of the manifold.
 26. The dispensingdevice of claim 25, wherein said tip connector is provided with a barbedproximal end.
 27. The dispensing device of claim 25, wherein the distalends of the cannulae are retained within the side-by-side lumens of thetip connector with an adhesive or by overmolding the cannulae in thelumens.
 28. The dispensing device of claim 25, further comprising ahousing enclosing at least a portion of the cannulae and the manifold.29. The dispensing device of claim 25, wherein the tip connectorcomprises a distal end having two apertures, each in fluid connectionwith one of the side-by-side lumens therein.
 30. The dispensing deviceof claim 25, wherein the tip connector comprises at least one flatsurface on an outer surface thereof.
 31. The dispensing device of claim25, wherein the tip connector comprises multiple flat surfaces on anouter surface thereof.
 32. The dispensing device of claim 31, wherein abarbed proximal end of the tip connector is disposed in a distal end ofthe rigid tube, and the rigid tube comprises at least one tab biasedinward to retain the tip connector.
 33. The dispensing device of claim32, wherein the barbed proximal end of the tip connector is disposed ina distal end of the rigid tube, and the rigid tube comprises at leastone slot in the distal end of the rigid tube to align with a keyingfeature of the tip connector to resist rotation of the tip connector inthe rigid tube.
 34. The dispensing device of claim 25, wherein theflexible side-by-side cannulae are partially connected along theirlength.
 35. The dispensing device of claim 25, wherein the manifold isan H-connector having two separate lumens extending therethrough. 36.The dispensing device of claim 35, wherein the distal ends of the twoseparate lumens in the H-connector each comprise a first region and asecond region, the first region being distal with respect to the secondregion, the first region having a diameter greater than the secondregion.
 37. The dispensing device of claim 36, wherein the first regionhas a greater taper than the second region.
 38. The dispensing device ofclaim 36, wherein the proximal ends of the cannulae are retained withinthe second regions of the two separate lumens with an adhesive or byovermolding the cannulae in the lumens.
 39. The dispensing device ofclaim 25, wherein the proximal ends of the manifold comprise Luer-taperconnections for the syringes.
 40. The dispensing device of claim 28,wherein the proximal ends of the manifold comprise Luer-taperconnections for the syringes, the manifold is slidably disposed withinthe housing and the Luer-taper connections provide for an angulardisplacement relative to a centrally aligned position.
 41. Thedispensing device of claim 28, further comprising a brace disposed at aproximal end of the housing to secure the manifold therein, extendingproximally from the housing to engage with a frame for the syringes, toalign the syringes with the manifold.
 42. A dispensing device to delivera multiple component material to a location in vivo, the devicecomprising: a manifold having a proximal end and a distal end andmultiple separate lumens within said manifold, connectable on theproximal end of the manifold to multiple syringes for containing themultiple component material; a distal tip assembly comprising a tipconnector having separate side-by-side lumens within the tip connectorand an external thread at a distal end of the tip connector forconnecting a threaded dispensing tip; multiple flexible side-by-sidecannulae, each having a proximal end and a distal end, the proximal endof the cannulae each connected to a separate lumen at the distal end ofsaid manifold, and the distal end of the cannulae each connected to oneof the side-by-side lumens of said tip connector, establishing a fluidcommunication between said manifold and said distal tip assembly,wherein said side-by-side cannulae are optionally partially connectedalong a length and are split at the proximal end and the distal end; anda flexible overtube and a grommet through which the side-by-sidecannulae extend, the grommet being disposed in a distal end of a housingenclosing at least a portion of the manifold, and the flexible overtubeextending between the tip connector and the grommet.
 43. The dispensingdevice of claim 42, wherein the grommet comprises a barbed distal endover which the flexible overtube is disposed and the tip connectorcomprises a barbed proximal end over which the flexible overtube isdisposed.
 44. The dispensing device of claim 42, wherein the distal endsof the cannulae are retained within the side-by-side lumens of the tipconnector with an adhesive or by overmolding the cannulae in the lumens.45. The dispensing device of claim 42, further comprising a housingenclosing at least a portion of the cannulae and the manifold.
 46. Thedispensing device of claim 42, wherein the tip connector comprises adistal end having two apertures, each in fluid connection with one ofthe side-by-side lumens therein.
 47. The dispensing device of claim 42,wherein the tip connector comprises at least one flat surface on anouter surface thereof.
 48. The dispensing device of claim 42, whereinthe tip connector comprises multiple flat surfaces on an outer surfacethereof.
 49. The dispensing device of claim 42, wherein the flexibleside-by-side cannulae are partially connected along their length. 50.The dispensing device of claim 42, wherein the manifold is anH-connector having two separate lumens extending therethrough.
 51. Thedispensing device of claim 50, wherein the distal ends of the twoseparate lumens in the H-connector each comprise a first region and asecond region, the first region being distal with respect to the secondregion, the first region having a diameter greater than the secondregion.
 52. The dispensing device of claim 53, wherein the first regionhas a greater taper than the second region.
 53. The dispensing device ofclaim 51, wherein the proximal ends of the cannulae are retained withinthe second regions of the two separate lumens with an adhesive or byovermolding the cannulae in the lumens.
 54. The dispensing device ofclaim 42, wherein the proximal ends of the manifold comprise Luer-taperconnections for the syringes.
 55. The dispensing device of claim 45,wherein the proximal ends of the manifold comprise Luer-taperconnections for the syringes, the manifold is slidably disposed withinthe housing and the Luer-taper connections provide for an angulardisplacement relative to a centrally aligned position.
 56. Thedispensing device of claim 45, further comprising a brace disposed at aproximal end of the housing to secure the manifold therein, extendingproximally from the housing to engage with a frame for the syringes, toalign the syringes with the manifold.
 57. A dispensing device to delivera multiple component material to a location in vivo, the devicecomprising: a manifold having a proximal end and a distal end andmultiple separate lumens within said manifold, connectable on theproximal end of the manifold to multiple syringes for containing themultiple component material; a distal tip assembly comprising a tipconnector having separate side-by-side lumens within the tip connectorand an external thread at a distal end of the tip connector forconnecting a threaded dispensing tip; multiple flexible side-by-sidecannulae, each having a proximal end and a distal end, the proximal endof the cannulae each connected to a separate lumen at the distal end ofsaid manifold, and the distal end of the cannulae each connected to oneof the side-by-side lumens of said tip connector, establishing a fluidcommunication between said manifold and said distal tip assembly,wherein said side-by-side cannulae are optionally partially connectedalong a length and are split at the proximal end and the distal end; ahousing enclosing at least a portion of the cannulae and the manifold;and wherein the proximal ends of the manifold comprise Luer-taperconnections for the syringes, the manifold is slidably disposed withinthe housing and the Luer-taper connections provide for an angulardisplacement relative to a centrally aligned position.
 58. Thedispensing device of claim 57, wherein said tip connector is providedwith a barbed proximal end.
 59. The dispensing device of claim 57,wherein the distal ends of the cannulae are retained within theside-by-side lumens of the tip connector with an adhesive or byovermolding the cannulae in the lumens.
 60. The dispensing device ofclaim 57, wherein the tip connector comprises a distal end having twoapertures, each in fluid connection with one of the side-by-side lumenstherein.
 61. The dispensing device of claim 57, wherein the tipconnector comprises at least one flat surface on an outer surfacethereof.
 62. The dispensing device of claim 57, wherein the tipconnector comprises multiple flat surfaces on an outer surface thereof.63. The dispensing device of claim 57, further comprising a rigid tubethrough which the side-by-side cannulae extend, the rigid tube extendingbetween the distal tip assembly and a housing enclosing at least aportion of the manifold.
 64. The dispensing device of claim 63, whereina barbed proximal end of the tip connector is disposed in a distal endof the rigid tube, and the rigid tube comprises at least one tab biasedinward to retain the tip connector.
 65. The dispensing device of claim64, wherein the barbed proximal end of the tip connector is disposed ina distal end of the rigid tube, and the rigid tube comprises at leastone slot in the distal end of the rigid tube to align with a keyingfeature of the tip connector to resist rotation of the tip connector inthe rigid tube.
 66. The dispensing device of claim 57, furthercomprising a flexible overtube and a grommet through which theside-by-side cannulae extend, the grommet being disposed in a distal endof the housing, and the flexible overtube extending between the tipconnector and the grommet.
 67. The dispensing device of claim 66,wherein the grommet comprises a barbed distal end over which theflexible overtube is disposed and the tip connector comprises a barbedproximal end over which the flexible overtube is disposed.
 68. Thedispensing device of claim 57, wherein the flexible side-by-sidecannulae are partially connected along their length.
 69. The dispensingdevice of claim 57, wherein the manifold is an H-connector having twoseparate lumens extending therethrough.
 70. The dispensing device ofclaim 69, wherein the distal ends of the two separate lumens in theH-connector each comprise a first region and a second region, the firstregion being distal with respect to the second region, the first regionhaving a diameter greater than the second region.
 71. The dispensingdevice of claim 70, wherein the first region has a greater taper thanthe second region.
 72. The dispensing device of claim 70, wherein theproximal ends of the cannulae are retained within the second regions ofthe two separate lumens with an adhesive or by overmolding the cannulaein the lumens.
 73. The dispensing device of claim 57, further comprisinga brace disposed at a proximal end of the housing to secure the manifoldtherein, extending proximally from the housing to engage with a framefor the syringes, to align the syringes with the manifold.
 74. Adispensing device to deliver a multiple component material to a locationin vivo, the device comprising: a manifold having a proximal end and adistal end and multiple separate lumens within said manifold,connectable on the proximal end of the manifold to multiple syringes forcontaining the multiple component material; a distal tip assemblycomprising a tip connector having separate side-by-side lumens withinthe tip connector and an external thread at a distal end of the tipconnector for connecting a threaded dispensing tip; multiple flexibleside-by-side cannulae, each having a proximal end and a distal end, theproximal end of the cannulae each connected to a separate lumen at thedistal end of said manifold, and the distal end of the cannulae eachconnected to one of the side-by-side lumens of said tip connector,establishing a fluid communication between said manifold and said distaltip assembly, wherein said side-by-side cannulae are optionallypartially connected along a length and are split at the proximal end andthe distal end; a housing enclosing at least a portion of the cannulaeand the manifold; and a brace disposed at a proximal end of the housingto secure the manifold therein, extending proximally from the housing toengage with a frame for the syringes, to align the syringes with themanifold.
 75. The dispensing device of claim 74, wherein said tipconnector is provided with a barbed proximal end.
 76. The dispensingdevice of claim 74, wherein the distal ends of the cannulae are retainedwithin the side-by-side lumens of the tip connector with an adhesive orby overmolding the cannulae in the lumens.
 77. The dispensing device ofclaim 74, wherein the tip connector comprises a distal end having twoapertures, each in fluid connection with one of the side-by-side lumenstherein.
 78. The dispensing device of claim 74, wherein the tipconnector comprises at least one flat surface on an outer surfacethereof.
 79. The dispensing device of claim 74, wherein the tipconnector comprises multiple flat surfaces on an outer surface thereof.80. The dispensing device of claim 74, further comprising a rigid tubethrough which the side-by-side cannulae extend, the rigid tube extendingbetween the distal tip assembly and a housing enclosing at least aportion of the manifold.
 81. The dispensing device of claim 80, whereina barbed proximal end of the tip connector is disposed in a distal endof the rigid tube, and the rigid tube comprises at least one tab biasedinward to retain the tip connector.
 82. The dispensing device of claim81, wherein the barbed proximal end of the tip connector is disposed ina distal end of the rigid tube, and the rigid tube comprises at leastone slot in the distal end of the rigid tube to align with a keyingfeature of the tip connector to resist rotation of the tip connector inthe rigid tube.
 83. The dispensing device of claim 74, furthercomprising a flexible overtube and a grommet through which theside-by-side cannulae extend, the grommet being disposed in a distal endof a housing enclosing at least a portion of the manifold, and theflexible overtube extending between the tip connector and the grommet.84. The dispensing device of claim 83, wherein the grommet comprises abarbed distal end over which the flexible overtube is disposed and thetip connector comprises a barbed proximal end over which the flexibleovertube is disposed.
 85. The dispensing device of claim 74, wherein theflexible side-by-side cannulae are partially connected along theirlength.
 86. The dispensing device of claim 74, wherein the manifold isan H-connector having two separate lumens extending therethrough. 87.The dispensing device of claim 86, wherein the distal ends of the twoseparate lumens in the H-connector each comprise a first region and asecond region, the first region being distal with respect to the secondregion, the first region having a diameter greater than the secondregion.
 88. The dispensing device of claim 87, wherein the first regionhas a greater taper than the second region.
 89. The dispensing device ofclaim 87, wherein the proximal ends of the cannulae are retained withinthe second regions of the two separate lumens with an adhesive or byovermolding the cannulae in the lumens.
 90. The dispensing device ofclaim 74, wherein the proximal ends of the manifold comprise Luer-taperconnections for the syringes.
 91. The dispensing device of claim 74,wherein the proximal ends of the manifold comprise Luer-taperconnections for the syringes, the manifold is slidably disposed withinthe housing and the Luer-taper connections provide for an angulardisplacement relative to a centrally aligned position.